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Diagnostic Study of Quantitative Imaging and Spectroscopy in Patients With Multiple Sclerosis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2009 by Office of Rare Diseases (ORD).
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00006060
First Posted: July 6, 2000
Last Update Posted: March 12, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Pennsylvania
Information provided by:
Office of Rare Diseases (ORD)
  Purpose

OBJECTIVES: I. Determine by quantitative magnetic resonance imaging measurements the change in the total volume of brain parenchyma as well as its gray and white matter, T2 and enhanced T1 lesion volume, and the magnetization transfer ratio histogram parameters, and correlate these measurements with clinical measures of disability in patients with multiple sclerosis.

II. Measure the quantity of whole brain N-acetylaspartate in patients with multiple sclerosis and compare these values to those from age matched controls.

III. Determine the correlation between specific neuropsychological tests which assess global cognitive functioning and the quantitative measurements taken in these patients in this study.


Condition Intervention
Multiple Sclerosis Drug: standard gadolinium contrast

Study Type: Observational

Resource links provided by NLM:


Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment: 100
Study Start Date: April 1999
Detailed Description:

PROTOCOL OUTLINE:

Patients undergo magnetic resonance imaging and spectroscopy with standard gadolinium contrast followed by neuropsychological testing every 6 months for 5 years. An equal number of age and sex matched healthy patients act as a control group and undergo magnetic resonance imaging and spectroscopy without standard gadolinium contrast every 6 months for 5 years.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

  • Diagnosis of multiple sclerosis Relapsing-remitting defined as 2 exacerbations and a worsening of neurologic function over 1 day followed by at least 30 days of no progression OR Secondary-progressive defined as increase of at least 1.0 unit on Expanded Disability Status Scale (EDSS) in past 2 years with or without exacerbations

--Prior/Concurrent Therapy--

  • Biologic therapy: Prior interferon beta 1A, 1B, or glatiramer acetate No concurrent interferon beta 1A, 1B, or glatiramer acetate
  • Endocrine therapy: Concurrent oral and IV corticosteroids allowed

--Patient Characteristics--

  • Performance status: EDSS no greater than 7.0
  • Hematopoietic: No hematologic dysfunction including hemolytic anemia
  • Hepatic: No hepatic dysfunction
  • Renal: No renal dysfunction
  • Cardiovascular: No cardiac pacemaker
  • Other: Not pregnant or nursing Negative pregnancy test No intracranial clips, metal implants, or external clips within 10 mm of head No metal in eyes No known gadolinium texaphyrin allergy No known claustrophobia
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006060


Contacts
Contact: Robert I. Grossman, MD 212-263-3269

Locations
United States, New York
New York University Medical Center Recruiting
New York, New York, United States, 10016
Contact: Lois J. Mannon, BSRT, (MR) (R) CCRC    212-263-3783    lois.mannon@med.nyu.edu   
Principal Investigator: Robert I. Grossman, MD         
Sponsors and Collaborators
National Center for Research Resources (NCRR)
University of Pennsylvania
Investigators
Study Chair: Robert I. Grossman, MD New York University
  More Information

ClinicalTrials.gov Identifier: NCT00006060     History of Changes
Other Study ID Numbers: 199/15245
UPSM-704-0
UPSM-070300
UPSM-NS-29029
First Submitted: July 5, 2000
First Posted: July 6, 2000
Last Update Posted: March 12, 2009
Last Verified: March 2009

Keywords provided by Office of Rare Diseases (ORD):
multiple sclerosis
neurologic and psychiatric disorders
rare disease

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases


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